At a glance
ClinicalIndex Comparison Record- ✓Age 18–99 years
- ✓Advanced intra-abdominal tumor, metastatic or recurrent, biopsy-proven, digestive tract origin
- ✓At least two index non-visceral intra-abdominal tumors >1 cm³ in volume, grossly visible, amenable to biopsy and injection
- ✓Scheduled for standard-of-care abdominal laparoscopic surgery and potentially eligible for definitive tumor removal
- ✕Pregnant or lactating
- ✕Investigational drug use within 30 days prior to enrollment
- ✕Immunosuppressive medication including corticosteroids within 30 days prior to enrollment
- ✕Active chemotherapy or radiotherapy within 4 weeks of investigational agent injection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal Tumors
In Brief
A Phase 1 clinical trial evaluating Lipopolysaccharide for Abdominal Cancer and Malignancy. Completed, enrolled 12 participants across 2 sites.
Signals
Detailed Summary
The purpose of this research study is to determine whether a sterile bacteria wall chemical, called lipopolysaccharide (LPS), can be injected safely into abdominal tumors during routine laparoscopic surgery performed as a preliminary procedure in patients who will subsequently undergo a larger planned operation to remove abdominal tumors. The researchers will biopsy the tumor before injection and then again at the time of the larger operation to assess whether any effect of the treatment can be measured.
Study Details
Timeline
Arms & Interventions
Injection of Lipopolysaccharide into one abdominal tumor
Interventions
One tumor will be injected with 1 ug LPS (investigational drug) over approximately one minute